Principal Quality Engineer

Olympus Corporation; Center Valley (Lehigh County); On-site; USD 90,000 - 120,000; Full time

Job summary

Olympus Corporation in Center Valley is hiring for a role focused on Product Quality, leveraging problem-solving expertise and leadership to improve product quality, resolve issues, and ensure patient safety.

The ideal candidate will have extensive experience in FDA regulated environments and will train CAPA Site Leads, supporting high-visibility projects and investigations.

Qualifications

• 8 years’ experience in an FDA regulated environment.
• Ability to manage multiple projects and lead cross-functional teams.
• Proficient with DMAIC/Lean Six Sigma tools and statistics.

Responsibilities

• Train and support CAPA Site Leads in technical methods.
• Deploy and oversee Design Assurance Quality training.
• Support high-priority complaint investigations.

Skills

Problem-solving expertise

Leadership acumen

Quality problem-solving tools

Data analysis

Statistical methods

Interpersonal skills

Education

BS degree in engineering or life science

Six Sigma Green Belt Certification

Tools

Word

Excel

PowerPoint

Project

Visio

Job description

Job Description

This role focuses on Product Quality and drives Patient Focus by leveraging problem‑solving expertise and leadership acumen to accelerate product quality improvement, resolve issues and ensure patient safety and customer satisfaction.

Job Duties

• Train, coach, and support CAPA Site Leads in the application of technical and analytical methods that accelerate CAPA closure and effectiveness; provide coaching for CAPA owners to drive the development of sound problem‑solving and technical design review habits and techniques across Olympus.
• Ability to support the use of quality problem‑solving tools such as Root Cause Analysis, 5 Whys, Ishikawa, etc.
• Deploy and oversee a Design Assurance Quality Engineer training and development syllabus supporting the development of a patient‑focused Quality Mindset and technical rigor across the Design Quality Assurance function.
• Leverages extensive technical experience to support high‑visibility new product development, sustaining engineering and CAPA efforts as assigned by Management.
• Supports high‑priority complaint investigations, signal detection, and product issue escalations.
• Other Quality Assurance responsibilities as assigned by Management.

Job Qualifications – Required

• BS degree or equivalent in an engineering or life science discipline.
• Minimum of 8 years’ experience working in an FDA regulated environment.
• Demonstrated ability to manage and complete multiple projects and objectives and lead cross‑functional teams.
• Proficient with DMAIC/ Lean Six Sigma /Black Belt tools to analyze, drive root cause, and solve difficult problems.
• Proficient with statistics, sampling strategies, quality systems trending, and process capability.
• Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDAQSRs, ISO 13485, ISO 14971.
• Must be self‑motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally.
• Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
• Demonstrated ability to coach and mentor others.
• Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio).
• Demonstrates the highest ethical standards and actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
• Six Sigma Green Belt Certification required.
• Ability to travel up to 20% of time domestically and internationally.

Job Qualifications – Preferred

• Minimum of 3 years’ experience working in Medical Device or Pharma.
• Six Sigma Black Belt is preferred.

Equal Employment Opportunity & Accommodations

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.